Pumpkin Seeds or Oil Lower Serum Triglyceride Levels in Individuals With Hyperlipidaemia

NCT ID: NCT07123844

Last Updated: 2025-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-11-03

Brief Summary

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Aim of the Study:

This randomized controlled experimental study aimed to evaluate the effects of cholesterol-restricted diets enriched with pumpkin seeds and pumpkin seed oil on cardiovascular risk factors-specifically serum lipid profile (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides), blood pressure, and anthropometric measurements (body weight, body mass index, body fat percentage, and fat mass)-in individuals with hyperlipidemia.

Research Questions:

Does the nutritional intervention lead to a reduction in serum total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and triglyceride (TG) levels, as well as an increase in high-density lipoprotein cholesterol (HDL-C) levels across all study groups?

Do the groups receiving diets enriched with pumpkin seeds or pumpkin seed oil show greater improvements in lipid profile (TC, LDL-C, TG) and a more pronounced increase in HDL-C compared to the control group?

Does the nutritional intervention result in reductions in body weight, BMI, body fat percentage, and fat mass in all study groups?

Detailed Description

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The aim of this randomized controlled trial was to investigate the effects of cholesterol-restricted diets enriched with pumpkin seeds or pumpkin seed oil on cardiovascular risk factors in individuals with hyperlipidemia. Specifically, the study aimed to determine the effects of these dietary interventions on serum lipid parameters (total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides), blood pressure (systolic and diastolic), and anthropometric measurements (body weight, body mass index, body fat percentage, and fat mass) over a 28-day period.

The study hypothesizes that incorporating pumpkin seeds or pumpkin seed oil into a cholesterol-restricted diet will improve serum lipid parameters and blood pressure, and reduce anthropometric measurements.

Research Questions:

Primary Questions:

Does consumption of a cholesterol-restricted diet in individuals with hyperlipidemia result in statistically significant improvements in the serum lipid profile (i.e., decreases in TC, LDL-C, and TG, and increases in HDL-C)?

Do diets enriched with pumpkin seeds or pumpkin seed oil lead to greater improvements in these lipid parameters compared to a control group that only follows a cholesterol-restricted diet?

Secondary Questions:

Does the intervention (regardless of group) lead to reductions in anthropometric indices such as body weight, BMI, body fat percentage, and fat mass?

Are reductions in anthropometric measurements and improvements in blood pressure more pronounced in groups consuming diets enriched with pumpkin seeds or pumpkin seed oil compared to the control group?

Conditions

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Hyperlipidemia Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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pumpkin seed

30 g/day pumpkin seed and low cholesterol diet (28 days)

Group Type EXPERIMENTAL

low cholesterol diet

Intervention Type DIETARY_SUPPLEMENT

low cholesterol diet

pumpkin seed oil

15 g/day pumpkin seed oil and low cholesterol diet (28 days)

Group Type EXPERIMENTAL

low cholesterol diet

Intervention Type DIETARY_SUPPLEMENT

low cholesterol diet

control

low cholesterol diet (28 days)

Group Type EXPERIMENTAL

low cholesterol diet

Intervention Type DIETARY_SUPPLEMENT

low cholesterol diet

Interventions

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low cholesterol diet

low cholesterol diet

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

Participants must meet all of the following criteria:

* Aged between 19 and 64 years
* Body mass index (BMI) between 25.0 and 30.0 kg/m²
* Triglyceride (TG) level \> 200 mg/dL
* Low-density lipoprotein cholesterol (LDL-C) between 130 and 190 mg/dL
* Fasting blood glucose \< 110 mg/dL
* Blood pressure below 140/90 mmHg

Exclusion Criteria

* Individuals will be excluded if they meet any of the following criteria:
* Diagnosis of any systemic disease, including:
* Diabetes mellitus
* Hypertension
* Cancer
* Metabolic syndrome
* Chronic kidney disease
* Use of any medication that affects blood lipid, glucose, and pressure levels
* Presence of food allergies (e.g., to pumpkin seeds or oil)
* Current or recent nutritional treatment or dietary therapy
* Pregnancy or breastfeeding
* Diagnosed psychiatric disorders
* Known congenital metabolic disorders
Minimum Eligible Age

19 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Okan University

OTHER

Sponsor Role collaborator

Kastamonu University

OTHER

Sponsor Role lead

Responsible Party

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Kevser Karli

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hande Öngün Yılmaz, pHD

Role: STUDY_DIRECTOR

[email protected]

Locations

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Kastamonu Training and Research Hospital

Kastamonu, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2022--KAEK-37

Identifier Type: -

Identifier Source: org_study_id

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